GAITHERSBURG, Md., Feb. 01, 2018 (GLOBE NEWSWIRE) -- OpGen, Inc. (OPGN) announced today that it has introduced a Research Use Only (RUO) Acuitas® AMR Gene Panel u5.47 test for commercial sale. The Acuitas AMR Gene Panel u5.47 test was developed to detect the most common bacterial causes of cUTI directly from urine (E. coli, K. pneumoniae, P. aeruginosa, P. mirabilis, E. faecalis) and isolated colonies. Additionally, the gene panel detects 47 gene targets that convey resistance to antibiotics.
The RUO AMR Gene Panel u5.47 is available for infection control purposes and pharmaceutical surveillance research as a Research Use Only test for complicated urinary tract infection (cUTI). The RUO Acuitas AMR Gene Panel u5.47 will be available while the company completes clinical trials and regulatory submissions to support U.S. Food and Drug Administration (FDA) approval for broader clinical use.
The RUO Acuitas AMR Gene Panel u5.47 detects over 600 multidrug-resistance genetic subtypes as predictors of resistance to the following antibiotic classes: Aminoglycosides, Carbapenems, Cephalosporins, Fluoroquinolones, Polymyxins, Penicillins, Sulfonamides, Trimethoprim and Vancomycin. Test results are available in under three hours compared with traditional microbiology methods, which can take two to three days to provide results.
The test has an easy-to-use protocol and reporting software designed to handle the workflow in a clinical microbiology lab environment with up to four samples per test run. The RUO Acuitas AMR Gene Panel employs industry standard PCR and DNA purification technology. Gene families detected include: KPC, NDM, VIM, IMP, OXA, CTXM-1, CTXM-9, CMY, MCR, and resistance genes to fluoroquinolone antibiotics.
Evan Jones, chairman & CEO of OpGen, stated, “The new RUO Acuitas AMR Gene Panel u5.47 was designed to improve patient outcomes and the appropriate use of antibiotics. During 2017, we have performed initial development and analytical validation of this important new technology. With initial clinical verifications underway, we are pleased to introduce the test for commercial sale for Research Use Only to hospitals for infection control purposes and for pharmaceutical surveillance studies.”
OpGen, Inc. is harnessing the power of informatics and genomic analysis to provide complete solutions for patient, hospital and network-wide infection prevention and treatment. Learn more at www.opgen.com and follow OpGen on Twitter and LinkedIn.
OpGen, andAcuitas, are registered trademarks of OpGen, Inc.
This press release includes statements relating to OpGen’s RUO Acuitas AMR Gene Panel u5.47 and its launch for Research Use Only. These statements and other statements regarding OpGen’s future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals, other healthcare providers and pharmaceutical companies, the success of our commercialization efforts for the Research Use Only product offering, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.